FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INJECTOR HANDLE WITH SYRINGE
K Number: K880987
·
Decision May 13, 1988
Classifications
1
FEI Numbers
124
Registration Numbers
124
Same Product Code
209
Applicant Total
21
Review Days
66
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Basic Information
- Device Name
- INJECTOR HANDLE WITH SYRINGE
- K Number
- K880987
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1650
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Applied Vascular Devices, Inc.
- Date Received
- March 8, 1988
- Decision Date
- May 13, 1988
- Product Code
- DXT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DXT | Injector And Syringe, Angiographic | FDA class 2 | Cardiovascular |
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Disposable Syringes with Accessories for Power Injectors (900103T); Disposable Syringes with Accessories for Power Injectors (900103H); Disposable Syringes with Accessories for Power Injectors (801800H); Disposable Syringes with Accessories for Power Injectors (800099T); Disposable Syringes with Accessories for Power Injectors (800099H); Disposable Syringes with Accessories for Power Injectors (800096T); Disposable Syringes with Accessories for Power Injectors (800096H); Disposable Syr
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Other Clearances by Applied Vascular Devices, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K911730 | SURGICAL OBTURATOR WITH SEAL | Dec 23, 1991 | Substantially Equivalent |
| K911589 | DISPOSABLE SURGICAL TROCAR WITH SEAL | Jul 5, 1991 | Substantially Equivalent |
| K910339 | AVD INTIMAX OCCLUSION CATHETER | May 29, 1991 | Substantially Equivalent |
| K910372 | INTIMAX THROMBECTOMY CATHETER | Apr 26, 1991 | Substantially Equivalent |
| K911181 | INTIMAX(TM) IRRIGATION CATHETER | Apr 18, 1991 | Substantially Equivalent |
| K910493 | AVD INTIMAX CHOLANGIOGRAPHY CATHETER | Mar 28, 1991 | Substantially Equivalent |
| K903848 | DIAGNOSTIC INTRASCULAR CATHETER | Mar 25, 1991 | Substantially Equivalent |
| K905738 | OPERATIVE CHOLANGIOGRAPHIC CATHETER | Mar 21, 1991 | Substantially Equivalent |
| K910079 | DISPOSABLE INTRODUCER SHEATH | Feb 27, 1991 | Substantially Equivalent |
| K902256 | IRRIGATION CATHETER 4, 6 AND 10 FRENCH | Feb 15, 1991 | Substantially Equivalent |